Amgen Inc. v. F. Hoffmann-LaRoche LTD et al Doc.

1388
Case 1:05-cv-12237-WGY Document 1388 Filed 10/15/2007 Page 1 of 5

IN THE UNITED STATES DISTRICT COURT

IN AND FOR THE DISTRICT OF MASSACHUSETTS

AMGEN INC., )
)
Plaintiff, )
) Civil Action No.: 1:05-CV-12237 WGY
v. )
)
F. HOFFMANN-LA ROCHE LTD, a )
Swiss Company, ROCHE DIAGNOSTICS )
GMBH, a German Company, and )
HOFFMANN LA ROCHE INC., a New )
Jersey Corporation, )
)
Defendants. )
)

AMGEN’S MOTION FOR A CORRECTIVE INSTRUCTION REGARDING

ROCHE’S PATENT ON PEGYLATED ERYTHROPOIETIN
Amgen requests that this Court provide a corrective instruction to the Jury regarding the

relevance to infringement of Roche’s patent (the “Bailon Patent”) on peg-EPO. Roche’s opening

statement revealed that it will rely on its peg-EPO patent as a defense to infringement. However,

Roche’s patent is irrelevant to literal infringement, and it is likely to confuse and mislead the jury

in the absence of a corrective instruction. Amgen respectfully requests that this Court give the

following corrective instruction to the Jury prior to Roche commencing its case for

noninfringement:

Roche contends that its MIRCERA (peg-EPO) product and process

accused of infringement represents an improvement to the
inventions described in the Lin patent claims. Proof of this fact
does not necessarily mean that Roche’s accused MIRCERA
product and process do not infringe Dr. Lin’s patent claims.
Furthermore, MIRCERA may infringe the Lin patent claims
whether or not Roche has a patent on MIRCERA. Improvements
may be separately patentable, yet still infringe another’s patent.

The tests for infringement remain as I have instructed you. As

long as you find that Roche’s MIRCERA product and process
include all of the elements of at least one of the asserted patent
claims, either literally or under the doctrine of equivalents, then
you must find that the patent claim(s) will be infringed by Roche’s

AMGEN’S MOTION FOR CORRECTIVE

MPK 133550-1.041925.0023 1 INSTRUCTION RE ROCHE’S PATENT
CIVIL ACTION NO. 1:05-CV-12237 WGY
Dockets.Justia.com
 Case 1:05-cv-12237-WGY Document 1388 Filed 10/15/2007 Page 2 of 5

product and process, despite what Roche contends to be

improvements.
Courts have properly excluded evidence of separate patentability as prejudicial when

Defendants cannot make the requisite showing of legal relevance.1 In addition, the Federal

Circuit Bar Association has promulgated a model Jury instruction (recited above) to moderate

the potential prejudice from arguments of separate patentability for a product accused of

infringement.

Separate patentability is not relevant to the issue of literal infringement, and is relevant

under only limited circumstances to infringement under the doctrine of equivalents not

applicable here.2 Separate patentability is probative of insubstantial differences when the literal

limitations of a claim are not met and the accused equivalent element lends patentable distinction

to the product accused of infringement because of unexpected results.3 This Court has already

determined that Roche’s peg-EPO infringes claim 1 of the ‘422 Patent, and Amgen is asking the

Jury to find literal infringement of the other claims in the other asserted patents.

The facts surrounding the Bailon Patent also negate any relevance to Roche’s Reverse

Doctrine of Equivalence defense. The Bailon Patent admits that peg-EPO works in the same

way as EPO:

The conjugates of this invention have the same uses as EPO. In

particular, the conjugates of this invention are useful to treat
patients by stimulating the division and differentiation of
committed erythroid progenitors in the bone marrow in the same
way EPO is used to treat patients.4
The BLA for MIRCERA also admits that peg-EPO works in the same way as EPO:

The mode of action for RO0503821 is described by the following

key mechanism: receptor binding and stimulation of production
of erythroid progenitor cells in the bone marrow.5

1
See Fiskars, Inc. v. Hunt Mfg. Co., 221 F.3d 1318, 1324 (Fed. Cir. 2000).
2
Atlas Powder Co. v. E. I. DuPont De Nemours & Co., 750 F.2d 1569, 1580 (Fed. Cir. 1984).
3
Id.
4
The Bailon Patent at col. 2:22-27 (emphasis added)
5
Mircera BLA Sec. 3.2.S, ITC-R-BLA-00004024 - 649 at 4200 (emphasis added)

AMGEN’S MOTION FOR CORRECTIVE

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Thus, the separate patentability of the Bailon Patent cannot establish the Reverse Doctrine of

Equivalence because the Bailon Patent itself states that the way in which peg-EPO functions is

the same as the invention claimed by the Lin Patents. This Court also rejected Roche’s argument

of noninfringement under the Reverse Doctrine of Equivalents when it granted Amgen’s motion

for summary judgment of infringement for claim 1 of the ‘422 Patent.6

Finally, Roche may argue that the Bailon Patent is relevant to whether the EPO made in

Germany is materially changed by PEGylation. The EPO made in Germany is materially

changed if PEGylation imparts a significant change to the structure and properties of the EPO

which changes it’s basic utility.7 As Roche’s admissions cited above show, the function and
utility of EPO has not been changed by PEGylation, and this Court’s prior decision that peg-EPO

contains human erythropoietin shows that the structure of EPO has not been changed by

PEGylation.

The Model Jury Instructions for the Federal Circuit Bar Association set out a specific

corrective instruction for those cases in which separate patentability is relevant, and admitted as

evidence into a case. Courts readily provide such corrective jury instructions to prevent juror

confusion over the import of separate patentability. For example, in The Read Corp., v.

Powerscreen of America, Inc., No. 96-11025, the Court instructed the jury that

[i]f there are other things added, made more sophisticated, made
better, it still infringes so long as it has every element of what’s
claimed. Miss an element and there’s no infringement. But add to
the elements, make the elements better, is still infringement so long
as it has every element of the claim.8

6
August 28, 2007 Order (“Amgen's Motion for Summary Judgment is ALLOWED as to
infringement of the '422 patent.”)
7
Eli Lilly & Co. v. Am. Cyanamid Co., 82 F.3d 1568, 1573 (Fed. Cir. 1996)
8
Read, Feb. 23, 2001 Tr. at 15. See also, Amstar Corp., v. Envirotech Corp., 730 F.2d 1476,
1482 (Fed. Cir. 1984) (“Modification by mere addition of elements or functions, whenever made
cannot negate infringement . . . .”); Nat’l Presto Indus., Inc. v. W. Bend Co., 76 F.3d 1185, 1191-
92 (Fed. Cir. 1996) (“The grant of a separate patent on the accused device does not automatically
avoid infringement either literal or by equivalency. Improvements or modifications may indeed
be separately patentable if the requirements of patentability are met, yet the device may not avoid
infringement of a the prior patent.”); Hoechst Celanese Corp. v. BP Chems. Ltd., 78 F.3d 1575,
(continued…)

AMGEN’S MOTION FOR CORRECTIVE

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A corrective instruction is appropriate in this case because Roche’s evidence of separate

patentability will likely confuse and mislead the jury on literal infringement.

Amgen requests that the Jury receive the Federal Circuit Bar Association model

instruction on separate patentability before Roche commences its defense on infringement.

DATED: October 15, 2007 Respectfully Submitted,

Of Counsel: AMGEN INC.,

Stuart L. Watt
Wendy A. Whiteford /s/ Michael R. Gottfried
Monique L. Cordray D. Dennis Allegretti (BBO# 545511)
Darrell G. Dotson Michael R. Gottfried (BBO# 542156)
Kimberlin L. Morley Patricia R. Rich (BBO# 640578)
Erica S. Olson DUANE MORRIS LLP
AMGEN INC. 470 Atlantic Avenue, Suite 500
One Amgen Center Drive Boston, MA 02210
Thousand Oaks, CA 91320-1789 Telephone: (857) 488-4200
(805) 447-5000 Facsimile: (857) 488-4201

Lloyd R. Day, Jr. (pro hac vice)

DAY CASEBEER MADRID & BATCHELDER LLP
20300 Stevens Creek Boulevard, Suite 400
Cupertino, CA 95014
Telephone: (408) 873-0110
Facsimile: (408) 873-0220

William G. Gaede III (pro hac vice)

McDERMOTT WILL & EMERY
3150 Porter Drive
Palo Alto, CA 94304
Telephone: (650) 813-5000
Facsimile: (650) 813-5100

Kevin M. Flowers (pro hac vice)

MARSHALL, GERSTEIN & BORUN LLP
233 South Wacker Drive
6300 Sears Tower
Chicago, IL 60606
Telephone: (312) 474-6300
Facsimile: (312) 474-0448

1582 (Fed. Cir. 1996) (“[t]he fact of separate patentability presents no legal or evidentiary
presumption of noninfringement”).

AMGEN’S MOTION FOR CORRECTIVE

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CERTIFICATE PURSUANT TO LOCAL RULE 7.1

I certify that counsel for the parties have conferred in an attempt to resolve or narrow

the issues presented by this motion and no agreement was reached.

/s/ Michael R. Gottfried

Michael R. Gottfried

CERTIFICATE OF SERVICE

I hereby certify that this document filed through the Electronic Case Filing (ECF) system

will be sent electronically to the registered participants as identified on the Notice of Electronic

Filing (NEF) and paper copies will be sent to those indicated as non registered participants on the

above date.

/s/ Michael R. Gottfried

Michael R. Gottfried

MPK 133550-1.041925.0023 1 CERTIFICATE OF SERVICE

CIVIL ACTION NO. 1:05-CV-12237 WGY